AU2013219968B2 - A process for detection and optional quantification of an analyte - Google Patents
A process for detection and optional quantification of an analyte Download PDFInfo
- Publication number
- AU2013219968B2 AU2013219968B2 AU2013219968A AU2013219968A AU2013219968B2 AU 2013219968 B2 AU2013219968 B2 AU 2013219968B2 AU 2013219968 A AU2013219968 A AU 2013219968A AU 2013219968 A AU2013219968 A AU 2013219968A AU 2013219968 B2 AU2013219968 B2 AU 2013219968B2
- Authority
- AU
- Australia
- Prior art keywords
- analyte
- buffer
- biological sample
- antibody
- detection
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Active
Links
- 239000012491 analyte Substances 0.000 title claims abstract description 93
- 238000000034 method Methods 0.000 title claims abstract description 52
- 238000001514 detection method Methods 0.000 title claims description 38
- 238000011002 quantification Methods 0.000 title claims description 15
- 150000001860 citric acid derivatives Chemical class 0.000 claims abstract description 57
- 239000007979 citrate buffer Substances 0.000 claims abstract description 54
- 239000012472 biological sample Substances 0.000 claims description 37
- 239000000872 buffer Substances 0.000 claims description 34
- 210000002966 serum Anatomy 0.000 claims description 30
- 229920001213 Polysorbate 20 Polymers 0.000 claims description 28
- 239000000256 polyoxyethylene sorbitan monolaurate Substances 0.000 claims description 28
- 235000010486 polyoxyethylene sorbitan monolaurate Nutrition 0.000 claims description 28
- 229940068977 polysorbate 20 Drugs 0.000 claims description 24
- 238000002965 ELISA Methods 0.000 claims description 22
- 101001012157 Homo sapiens Receptor tyrosine-protein kinase erbB-2 Proteins 0.000 claims description 22
- 102100030086 Receptor tyrosine-protein kinase erbB-2 Human genes 0.000 claims description 20
- 230000002452 interceptive effect Effects 0.000 claims description 20
- 239000000126 substance Substances 0.000 claims description 19
- 239000000243 solution Substances 0.000 claims description 17
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims description 15
- 238000003556 assay Methods 0.000 claims description 13
- 239000000523 sample Substances 0.000 claims description 13
- 238000005406 washing Methods 0.000 claims description 12
- 239000003153 chemical reaction reagent Substances 0.000 claims description 11
- 239000011248 coating agent Substances 0.000 claims description 10
- 238000000576 coating method Methods 0.000 claims description 10
- 238000010494 dissociation reaction Methods 0.000 claims description 7
- 239000002253 acid Substances 0.000 claims description 6
- 230000005593 dissociations Effects 0.000 claims description 6
- 239000002953 phosphate buffered saline Substances 0.000 claims description 6
- 102000004190 Enzymes Human genes 0.000 claims description 5
- 108090000790 Enzymes Proteins 0.000 claims description 5
- LOKCTEFSRHRXRJ-UHFFFAOYSA-I dipotassium trisodium dihydrogen phosphate hydrogen phosphate dichloride Chemical group P(=O)(O)(O)[O-].[K+].P(=O)(O)([O-])[O-].[Na+].[Na+].[Cl-].[K+].[Cl-].[Na+] LOKCTEFSRHRXRJ-UHFFFAOYSA-I 0.000 claims description 5
- NLJMYIDDQXHKNR-UHFFFAOYSA-K sodium citrate Chemical compound O.O.[Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O NLJMYIDDQXHKNR-UHFFFAOYSA-K 0.000 claims description 5
- 239000001509 sodium citrate Substances 0.000 claims description 5
- 239000007787 solid Substances 0.000 claims description 5
- 229920000136 polysorbate Polymers 0.000 claims description 4
- 229950008882 polysorbate Drugs 0.000 claims description 4
- 239000000758 substrate Substances 0.000 claims description 4
- 108010001336 Horseradish Peroxidase Proteins 0.000 claims description 3
- OHDRQQURAXLVGJ-HLVWOLMTSA-N azane;(2e)-3-ethyl-2-[(e)-(3-ethyl-6-sulfo-1,3-benzothiazol-2-ylidene)hydrazinylidene]-1,3-benzothiazole-6-sulfonic acid Chemical compound [NH4+].[NH4+].S/1C2=CC(S([O-])(=O)=O)=CC=C2N(CC)C\1=N/N=C1/SC2=CC(S([O-])(=O)=O)=CC=C2N1CC OHDRQQURAXLVGJ-HLVWOLMTSA-N 0.000 claims description 3
- OHDRQQURAXLVGJ-AXMZSLBLSA-N azane;(2z)-3-ethyl-2-[(z)-(3-ethyl-6-sulfo-1,3-benzothiazol-2-ylidene)hydrazinylidene]-1,3-benzothiazole-6-sulfonic acid Chemical compound [NH4+].[NH4+].S/1C2=CC(S([O-])(=O)=O)=CC=C2N(CC)C\1=N\N=C1/SC2=CC(S([O-])(=O)=O)=CC=C2N1CC OHDRQQURAXLVGJ-AXMZSLBLSA-N 0.000 claims description 3
- 210000004369 blood Anatomy 0.000 claims description 3
- 239000008280 blood Substances 0.000 claims description 3
- 239000003593 chromogenic compound Substances 0.000 claims description 3
- 239000012470 diluted sample Substances 0.000 claims description 3
- 230000003993 interaction Effects 0.000 claims description 3
- IKRZCYCTPYDXML-UHFFFAOYSA-N 2-hydroxypropane-1,2,3-tricarboxylic acid;hydrochloride Chemical compound Cl.OC(=O)CC(O)(C(O)=O)CC(O)=O IKRZCYCTPYDXML-UHFFFAOYSA-N 0.000 claims description 2
- KJTLSVCANCCWHF-UHFFFAOYSA-N Ruthenium Chemical compound [Ru] KJTLSVCANCCWHF-UHFFFAOYSA-N 0.000 claims description 2
- 230000015572 biosynthetic process Effects 0.000 claims description 2
- 210000002381 plasma Anatomy 0.000 claims description 2
- 102000005962 receptors Human genes 0.000 claims description 2
- 108020003175 receptors Proteins 0.000 claims description 2
- 229910052707 ruthenium Inorganic materials 0.000 claims description 2
- 239000003995 emulsifying agent Substances 0.000 claims 6
- 239000012875 nonionic emulsifier Substances 0.000 claims 3
- YRNWIFYIFSBPAU-UHFFFAOYSA-N 4-[4-(dimethylamino)phenyl]-n,n-dimethylaniline Chemical compound C1=CC(N(C)C)=CC=C1C1=CC=C(N(C)C)C=C1 YRNWIFYIFSBPAU-UHFFFAOYSA-N 0.000 claims 1
- 102000004160 Phosphoric Monoester Hydrolases Human genes 0.000 claims 1
- 108090000608 Phosphoric Monoester Hydrolases Proteins 0.000 claims 1
- 238000007865 diluting Methods 0.000 abstract description 3
- 229960000575 trastuzumab Drugs 0.000 description 57
- 239000003085 diluting agent Substances 0.000 description 26
- 238000011084 recovery Methods 0.000 description 24
- 238000003908 quality control method Methods 0.000 description 23
- 238000011088 calibration curve Methods 0.000 description 21
- 238000003018 immunoassay Methods 0.000 description 11
- 206010055113 Breast cancer metastatic Diseases 0.000 description 10
- 230000002378 acidificating effect Effects 0.000 description 9
- 102000004169 proteins and genes Human genes 0.000 description 6
- 108090000623 proteins and genes Proteins 0.000 description 6
- 239000000427 antigen Substances 0.000 description 5
- 102000036639 antigens Human genes 0.000 description 5
- 108091007433 antigens Proteins 0.000 description 5
- 239000011159 matrix material Substances 0.000 description 5
- 238000000670 ligand binding assay Methods 0.000 description 4
- 238000012286 ELISA Assay Methods 0.000 description 3
- 206010028980 Neoplasm Diseases 0.000 description 3
- 238000010790 dilution Methods 0.000 description 3
- 239000012895 dilution Substances 0.000 description 3
- 239000003814 drug Substances 0.000 description 3
- 102000051957 human ERBB2 Human genes 0.000 description 3
- 239000013610 patient sample Substances 0.000 description 3
- 230000001225 therapeutic effect Effects 0.000 description 3
- 238000002560 therapeutic procedure Methods 0.000 description 3
- UAIUNKRWKOVEES-UHFFFAOYSA-N 3,3',5,5'-tetramethylbenzidine Chemical compound CC1=C(N)C(C)=CC(C=2C=C(C)C(N)=C(C)C=2)=C1 UAIUNKRWKOVEES-UHFFFAOYSA-N 0.000 description 2
- 102000002260 Alkaline Phosphatase Human genes 0.000 description 2
- 108020004774 Alkaline Phosphatase Proteins 0.000 description 2
- 206010006187 Breast cancer Diseases 0.000 description 2
- 208000026310 Breast neoplasm Diseases 0.000 description 2
- KRKNYBCHXYNGOX-UHFFFAOYSA-K Citrate Chemical compound [O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O KRKNYBCHXYNGOX-UHFFFAOYSA-K 0.000 description 2
- DHMQDGOQFOQNFH-UHFFFAOYSA-N Glycine Chemical compound NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 description 2
- QAOWNCQODCNURD-UHFFFAOYSA-N Sulfuric acid Chemical compound OS(O)(=O)=O QAOWNCQODCNURD-UHFFFAOYSA-N 0.000 description 2
- 230000001580 bacterial effect Effects 0.000 description 2
- 229960004106 citric acid Drugs 0.000 description 2
- 231100000673 dose–response relationship Toxicity 0.000 description 2
- 229940079593 drug Drugs 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 229940088597 hormone Drugs 0.000 description 2
- 239000005556 hormone Substances 0.000 description 2
- 150000003839 salts Chemical class 0.000 description 2
- 238000012421 spiking Methods 0.000 description 2
- 239000001117 sulphuric acid Substances 0.000 description 2
- 235000011149 sulphuric acid Nutrition 0.000 description 2
- 230000003612 virological effect Effects 0.000 description 2
- IVLXQGJVBGMLRR-UHFFFAOYSA-N 2-aminoacetic acid;hydron;chloride Chemical compound Cl.NCC(O)=O IVLXQGJVBGMLRR-UHFFFAOYSA-N 0.000 description 1
- YASYEJJMZJALEJ-UHFFFAOYSA-N Citric acid monohydrate Chemical compound O.OC(=O)CC(O)(C(O)=O)CC(O)=O YASYEJJMZJALEJ-UHFFFAOYSA-N 0.000 description 1
- 238000008157 ELISA kit Methods 0.000 description 1
- 239000004471 Glycine Substances 0.000 description 1
- 239000012901 Milli-Q water Substances 0.000 description 1
- 102000003992 Peroxidases Human genes 0.000 description 1
- 101710100968 Receptor tyrosine-protein kinase erbB-2 Proteins 0.000 description 1
- 238000012801 analytical assay Methods 0.000 description 1
- 201000011510 cancer Diseases 0.000 description 1
- 230000009702 cancer cell proliferation Effects 0.000 description 1
- 238000006243 chemical reaction Methods 0.000 description 1
- 229960002303 citric acid monohydrate Drugs 0.000 description 1
- 230000000295 complement effect Effects 0.000 description 1
- 230000001086 cytosolic effect Effects 0.000 description 1
- 238000011161 development Methods 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 230000005847 immunogenicity Effects 0.000 description 1
- 238000011534 incubation Methods 0.000 description 1
- 230000005764 inhibitory process Effects 0.000 description 1
- 238000011835 investigation Methods 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 230000002018 overexpression Effects 0.000 description 1
- 108040007629 peroxidase activity proteins Proteins 0.000 description 1
- 238000010837 poor prognosis Methods 0.000 description 1
- 238000002360 preparation method Methods 0.000 description 1
- 238000002203 pretreatment Methods 0.000 description 1
- 229960000999 sodium citrate dihydrate Drugs 0.000 description 1
- HRXKRNGNAMMEHJ-UHFFFAOYSA-K trisodium citrate Chemical compound [Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O HRXKRNGNAMMEHJ-UHFFFAOYSA-K 0.000 description 1
Classifications
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
- G01N33/574—Immunoassay; Biospecific binding assay; Materials therefor for cancer
- G01N33/5748—Immunoassay; Biospecific binding assay; Materials therefor for cancer involving oncogenic proteins
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
- G01N33/5306—Improving reaction conditions, e.g. reduction of non-specific binding, promotion of specific binding
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
- G01N33/543—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
- G01N33/54393—Improving reaction conditions or stability, e.g. by coating or irradiation of surface, by reduction of non-specific binding, by promotion of specific binding
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
- G01N33/6854—Immunoglobulins
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
- G01N2333/435—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
- G01N2333/705—Assays involving receptors, cell surface antigens or cell surface determinants
- G01N2333/71—Assays involving receptors, cell surface antigens or cell surface determinants for growth factors; for growth regulators
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Immunology (AREA)
- Engineering & Computer Science (AREA)
- Chemical & Material Sciences (AREA)
- Molecular Biology (AREA)
- Biomedical Technology (AREA)
- Hematology (AREA)
- Urology & Nephrology (AREA)
- General Health & Medical Sciences (AREA)
- Biochemistry (AREA)
- Medicinal Chemistry (AREA)
- Cell Biology (AREA)
- Pathology (AREA)
- Microbiology (AREA)
- Physics & Mathematics (AREA)
- Analytical Chemistry (AREA)
- Biotechnology (AREA)
- Food Science & Technology (AREA)
- General Physics & Mathematics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Oncology (AREA)
- Organic Chemistry (AREA)
- Hospice & Palliative Care (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Peptides Or Proteins (AREA)
- Investigating Or Analysing Biological Materials (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| IN566/CHE/2012 | 2012-02-15 | ||
| IN566CH2012 | 2012-02-15 | ||
| PCT/IB2013/051193 WO2013121368A2 (en) | 2012-02-15 | 2013-02-14 | A process for detection and optional quantification of an analyte |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| AU2013219968A1 AU2013219968A1 (en) | 2014-10-02 |
| AU2013219968B2 true AU2013219968B2 (en) | 2018-11-08 |
Family
ID=48984858
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| AU2013219968A Active AU2013219968B2 (en) | 2012-02-15 | 2013-02-14 | A process for detection and optional quantification of an analyte |
Country Status (7)
| Country | Link |
|---|---|
| US (1) | US9638696B2 (es) |
| EP (1) | EP2815238B1 (es) |
| KR (1) | KR102076354B1 (es) |
| AU (1) | AU2013219968B2 (es) |
| ES (1) | ES2796253T3 (es) |
| NZ (1) | NZ700025A (es) |
| WO (1) | WO2013121368A2 (es) |
Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US10036745B2 (en) | 2012-10-03 | 2018-07-31 | Gyros Patent Ab | Method and kit for analyte determination at acidic conditions |
| EP3117211A4 (en) * | 2014-03-13 | 2017-10-11 | Pharmacophotonics, Inc. D/B/A Fast Biomedical | Improved measurement of body fluid volumes |
| ES2911415T3 (es) | 2015-06-08 | 2022-05-19 | Arquer Diagnostics Ltd | Métodos y kits |
| EP3304082B1 (en) | 2015-06-08 | 2020-05-13 | Arquer Diagnostics Limited | Methods for analysing a urine sample |
| US10027165B2 (en) * | 2016-06-20 | 2018-07-17 | Fairchild Semiconductor Corporation | Power supply circuit with secondary side to primary side communication |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20020090662A1 (en) * | 2000-08-15 | 2002-07-11 | Peter Ralph | Analytical method |
Family Cites Families (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4604348A (en) * | 1981-11-19 | 1986-08-05 | New York Blood Center, Inc. | Composition for use in immunoassays |
| US4657851A (en) * | 1984-01-03 | 1987-04-14 | Georgetown University | Breast cancer diagnostic blood test |
| US5256541A (en) * | 1991-11-06 | 1993-10-26 | Sangstat Medical Corporation | Detection of soluble alloantigen immune complexes |
| SE9201984D0 (sv) * | 1992-06-29 | 1992-06-29 | Pharmacia Biosensor Ab | Improvement in optical assays |
| DE19538641C2 (de) * | 1995-10-05 | 2000-09-21 | Privates Inst Bioserv Gmbh | Patientenspezifische Immunadsorber für die extrakorporale Apherese und Verfahren für deren Herstellung |
| US20030125536A1 (en) * | 1996-01-11 | 2003-07-03 | Corixa Corporation | Compositions and methods for the therapy and diagnosis of breast cancer |
| DE19963859A1 (de) * | 1999-12-30 | 2001-07-12 | Apotech Res & Dev Ltd | Bi- oder Oligomer eines Di-, Tri-, Quattro- oder Pentamers von rekombinanten Fusionsproteinen |
| US20080182796A1 (en) * | 2001-08-31 | 2008-07-31 | Syngenta Participations Ag | Modified Cry3A toxins and nucleic acid sequences coding therefor |
| US8937159B2 (en) * | 2009-12-16 | 2015-01-20 | Abbvie Biotherapeutics Inc. | Anti-HER2 antibodies and their uses |
-
2013
- 2013-02-14 US US14/379,186 patent/US9638696B2/en active Active
- 2013-02-14 ES ES13749422T patent/ES2796253T3/es active Active
- 2013-02-14 AU AU2013219968A patent/AU2013219968B2/en active Active
- 2013-02-14 EP EP13749422.5A patent/EP2815238B1/en active Active
- 2013-02-14 NZ NZ700025A patent/NZ700025A/en active IP Right Revival
- 2013-02-14 KR KR1020147025748A patent/KR102076354B1/ko active IP Right Grant
- 2013-02-14 WO PCT/IB2013/051193 patent/WO2013121368A2/en active Application Filing
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20020090662A1 (en) * | 2000-08-15 | 2002-07-11 | Peter Ralph | Analytical method |
Non-Patent Citations (2)
| Title |
|---|
| MAPLE, L. et al., "Development and validation of ELISA for Herceptin detection in human serum", Journal of Immunological Methods, (2004), vol. 295, no. 1-2, pages 169 - 182 * |
| ROCHE, J. A. et al., "Unmasking Potential Intracellular Roles for Dysferlin through Improved Immunolabeling Methods", Journal of Histochemistry and Cytochemistry, (2011), vol. 59, no. 11, pages 964 - 975 * |
Also Published As
| Publication number | Publication date |
|---|---|
| EP2815238B1 (en) | 2020-04-08 |
| WO2013121368A2 (en) | 2013-08-22 |
| US20160003826A1 (en) | 2016-01-07 |
| KR102076354B1 (ko) | 2020-02-10 |
| EP2815238A4 (en) | 2017-05-03 |
| AU2013219968A1 (en) | 2014-10-02 |
| WO2013121368A3 (en) | 2016-07-07 |
| EP2815238A2 (en) | 2014-12-24 |
| ES2796253T3 (es) | 2020-11-26 |
| NZ700025A (en) | 2018-07-27 |
| KR20150034676A (ko) | 2015-04-03 |
| US9638696B2 (en) | 2017-05-02 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FGA | Letters patent sealed or granted (standard patent) | ||
| PC | Assignment registered |
Owner name: BIOSIMILARS NEWCO LIMITED Free format text: FORMER OWNER(S): MYLAN GMBH; BIOCON LIMITED Owner name: BIOCON LIMITED Free format text: FORMER OWNER(S): MYLAN GMBH; BIOCON LIMITED |